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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K150448
Device Name NMI PICC III and NMI PICC IV
Applicant
Navilyst Medical, Inc.
26 Forest St.
Marlborough,  MA  01752
Applicant Contact WANDA CARPINELLA
Correspondent
Navilyst Medical, Inc.
26 Forest St.
Marlborough,  MA  01752
Correspondent Contact WANDA CARPINELLA
Regulation Number880.5970
Classification Product Code
LJS  
Date Received02/20/2015
Decision Date 03/19/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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